MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number A3915-17/27

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2023

Event Type  Injury  

Event Description

It was reported that the epidural catheter broke off during use and the tip of the catheter remained in the patient.The catheter was removed from the patient.Adverse patient effects are unknown.

Manufacturer Narrative

Other text: d4: udi number is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Evaluation codes: updated.No product or other evidence were provided, and the investigation could not confirm whether a quality related issue had resulted in the customer reported problem.The reported problem could not be verified and/or confirmed with confidence.The complaint description indicates that no product quality issues were observed by the user prior to application on the patient and the product was compromised during removal of the catheter.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No further action was conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.

• Brand Name: PORTEX CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17839462
• MDR Text Key: 324530957
• Report Number: 3012307300-2023-09356
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: A3915-17/27
• Device Lot Number: 4404520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention